NCT02569034

Brief Summary

Anhedonia, decreased motivation for and sensitivity to rewarding experiences, is present in at least 1/3 of community dwelling older adults and is a feature of various psychiatric and neurological disorders, including late-life depression and Parkinson's disease. Anhedonia is associated with cognitive deficits, as well as poor clinical outcomes and increased mortality. Recent research suggests that anhedonia comprises motivational (reward "wanting") and consummatory (reward "liking") aspects. However, previous research on anhedonia has failed to dissociate these components, which may explain the contradictory findings in the literature. Recently, the Effort-Expenditure for Rewards Task (EEfRT) was developed in an effort to dissociate reward components in anhedonia. The EEfRT is an effort-based decision-making task that measures reward "wanting", in contrast to commonly used anhedonia questionnaires, which focus on reward "liking." This novel task may provide a useful measure of components of anhedonia in older adults and in different patient populations. Thus far no data is available on this task in elderly individuals, and the cognitive and neural correlates of components of the task have not been investigated. Given the paucity of research on the neurobiology of anhedonia, cognitive neuroscience studies using this task could fill a gap in the literature. The investigators are developing a line of cognitive neuroscience studies examining anhedonia in community-dwelling older adults and in late-life depression and Parkinson's disease. This study will involve gathering pilot behavioral and functional magnetic resonance imaging (fMRI) data in young and older adults performing the EEfRT task. Understanding the brain mechanisms underlying anhedonia in older adults and in different patient populations will have a translational impact by elucidating biological targets for treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

October 2, 2015

Last Update Submit

November 9, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • fMRI Activity

    To quantify brain activity associated with reward "wanting," the investigators will contrast fMRI activation while participants view information about reward probability and choose to perform the easy or hard task with activity during fixation. The investigators will contrast activation during performance feedback and presentation of reward magnitude with activation during fixation to capture brain activity associated with reward "liking." Parameter estimates (ß) will be generated, which indicated relative strength of covariance between the data and the hemodynamic response function (HRF). The investigators will use a three-dimensional spatial contiguity threshold of 20 voxels and a statistical significance threshold of p ≤ .005 to decrease the likelihood of spurious findings.

    Approximately Day 14 (Visit 2)

  • EEfRT Task Test

    The EEfRT is a computerized task in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.

    Approximately Day 14 (Visit 2)

Secondary Outcomes (19)

  • Montreal Cognitive Assessment (MoCA)

    Baseline (Visit 1)

  • Dementia Rating Scale-2 (DRS-2)

    Baseline (Visit 1)

  • Card Stroop Task

    Baseline (Visit 1)

  • Letter-Number Sequencing (Wechsler Adult Intelligence Scale, 4th Edition)

    Baseline (Visit 1)

  • Trail Making Test Parts A and B

    Baseline (Visit 1)

  • +14 more secondary outcomes

Study Arms (2)

Young Adults

ACTIVE COMPARATOR

These participants will perform the Effort-Expenditure for Rewards Task (EEfRT) while an functional magnetic resonance imaging (fMRI) is performed. They will also complete a battery of both cognitive and anhedonia questionnaires.

Other: Functional Magnetic Resonance ImagingOther: Effort-Expenditure for Rewards Task

Older Adults

EXPERIMENTAL

These participants will perform the Effort-Expenditure for Rewards Task (EEfRT) while an functional magnetic resonance imaging (fMRI) is performed. They will also complete a battery of both cognitive and anhedonia questionnaires.

Other: Functional Magnetic Resonance ImagingOther: Effort-Expenditure for Rewards Task

Interventions

Both groups will have the fMRI performed once. The fMRI will be use to to dissociate activity associated with both reward "wanting" and reward "liking" using the EEfRT. Learning more about the brain basis of components of anhedonia in both young and older adults is important in the context of previous research showing that risk-taking behavior and reward sensitivity changes with age, enhancing the knowledge of anhedonia.

Also known as: fMRI
Older AdultsYoung Adults

Both groups with have the EEfRT performed once. The EEfRT is an effort-based decision-making task that measures reward "wanting", in contrast to commonly used anhedonia questionnaires, which focus on reward "liking." This novel task may provide a useful measure of components of anhedonia in older adults and in different patient populations.

Also known as: EEfRT
Older AdultsYoung Adults

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-38 or 60-80 years
  • Able to provide verbal and written consent
  • Right-handed
  • Native English speaker
  • At least 12 years of formal education

You may not qualify if:

  • Significant cognitive disturbance
  • Self-report of current or past history of psychiatric disturbance other than major depression (e.g., bipolar disorder, schizophrenia, alcohol and/or substance abuse)
  • Self-report of neurological disturbance (stroke, dementia, traumatic brain injury), chronic medical illness (HIV, metastatic cancer), or unstable medical conditions (cardiac or pulmonary disease)
  • Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks
  • Current anticholinergic, psychotropic (stimulants or dopamine agonists), or anti-epileptic use
  • Visual acuity difficulties that would interfere with task performance
  • Motor deficits that may interfere with the use of the dominant hand for performance of button press associated with the EEfRT task
  • MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Anhedonia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adam J Woods, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

February 1, 2016

Primary Completion

May 8, 2018

Study Completion

May 8, 2018

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations